Skills Based Counseling for Adherence and Depression in HIV+ Methadone Patients - 1

Depression Clinical Trial

Official title:

CBT for Depression & Adherence in HIV Methadone Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00218634
• Other study ID #: NIDA-18603-1
• Secondary ID: R01DA018603
• Status: Completed
• Phase: N/A
• First received: September 20, 2005
• Last updated: December 7, 2017
• Start date: February 2005
• Est. completion date: July 2009

Study information

• Verified date: December 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients with HIV, depression, and opioid-dependence are at high risk for poor health outcomes. This is a two-arm randomized controlled trial of cognitive-behavioral therapy for depression and HIV medication adherence in patients with opioid dependence who are receiving methadone maintenance treatment. The project is based on our pilot work with close attention to NIDA guidelines for a staged approach to treatment development and testing (Rounsaville et al., 2001).

Depression is highly comorbid with both HIV infection and with opioid dependence. Depression and substance abuse are both associated with poor adherence to antiretroviral medications. Patients with HIV, depression, and opioid dependence are at high risk for poor health outcomes. Cognitive-behavioral therapy is the most widely studied and efficacious psychosocial intervention for depression; and research by the PI and others has shown that cognitive-behavioral interventions have been successful in promoting adherence to HIV medications.

Description:

Symptoms of depression (i.e. low motivation, poor concentration, loss of interest, sad mood, suicidal ideation) that occur in the context of substance abuse or dependence can interfere with self-care behaviors necessary for maintaining HIV care, as well as interfere with potential benefit from an intervention that focuses on adherence alone. We hypothesize that teaching skills to cope with depression will improve the outcome from an adherence intervention to promote healthier living with HIV, in HIV+ opioid dependent individuals in methadone maintenance treatment.

Overview of Research Plan. Patients who are HIV positive and who are receiving methadone maintenance for opioid dependence will be randomized to treatment with either: (1) CBT, a combination of CBT for depression and HIV medication adherence, including a single session intervention for HIV medication adherence (Life-Steps, Safren et al., 2001) in conjunction with physician feedback regarding baseline study assessments or (2) the single session intervention for HIV medication adherence (Life-Steps, Safren et al., 2001) in conjunction with physician feedback regarding baseline study assessments. Participants will be followed for one-year post-randomization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• HIV seropositive

• Currently enrolled in methadone maintenance treatment for at least one month

• Current major or subsyndromal depression (subsyndromal depression is defined by major depression that does not meet full diagnostic criteria but with a clinical global impression of severity (CGI-S) of 2 (mildly ill))

• Is prescribed antiretroviral therapy for HIV and therefore under the care of a primary care provider.

• Between the ages of 18 and 65.

Exclusion Criteria:

• Active untreated, unstable, major mental illness (i.e., untreated psychosis or mania), or other Axis I psychiatric disorders (other than depression) that would interfere with the ability to participate (i.e. CGI-S >6)

• Unable or unwilling to provide informed consent.

• Currently in cognitive behavioral therapy for depression.

Related Conditions & MeSH terms

• Adherence
• Depression
• Depressive Disorder
• Heroin Dependence
• Methadone
• Motivational Interviewing
• Substance-Related Disorders

Intervention

Behavioral:
• CBT-AD
Cognitive behavioral therapy for adherence and depression consisting of 1 session focusing on adherence and 8 sessions consisting of cognitive behavioral therapy for medication adherence and depression.
• ETAU
Enhanced treatment as usual consisting of 1 session focused on adherence (the same session as the CBT-AD intervention) and 8 sessions for participants to complete self-reports and collect adherence data.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Medication Adherence at 3-month Follow-up Assessment	Post-treatment assessment in adherence to HIV medication. Doses taken were assessed by downloading information from the electronic pill cap and corroborated by participant self-report. Adherence was calculated as the number of doses taken over the time period divided by the number of doses prescribed.	3-month assessment
Primary	Percent Medication Adherence at 12-month Follow-up Assessment	Follow-up assessment in adherence to HIV medication. Doses taken were assessed by downloading information from the electronic pill cap and corroborated by participant self-report. Adherence was calculated as the number of doses taken over the time period divided by the number of doses prescribed.	12-month follow-up assessment
Secondary	Clinician-assessed Depression Rating at 3 Month Follow-up Assessment	Depression was assessed using the Montgomery-Asberg Depression Rating Scale (MADRS) by a clinical interviewer blind to participants' study condition. The scale ranges from 0 to 60 with 7-19 indicating mild depression and 20-34 indicating moderate depression.	3 month follow-up
Secondary	HIV Viral Load at 12-month Follow-up Assessment	HIV plasma RNA (log HIV viral load)at the 12-month follow-up assessment.	12-month follow-up assessment
Secondary	CD4+ Lymphocyte Count at 12-month Follow-up Assessment.	CD4+ lymphocyte cell count at 12-month follow-up assessment.	12-month follow-up assessment
Secondary	Clinician-assessed Depression at 12-month Follow-up Assessment	Depression was assessed using the Montgomery-Asberg Depression Rating Scale (MADRS) by a clinical interviewer blind to participants' study condition. The scale ranges from 0 to 60 with 7-19 indicating mild depression and 20-34 indicating moderate depression.	12-month follow-up assessment
Secondary	HIV Viral Load at 3-month Follow-up Assessment	HIV plasma RNA (log HIV viral load)at the 3-month follow-up assessment.	3-month assessment
Secondary	CD4+ Lymphocyte Count at 3-month Follow-up Assessment.	CD4+ lymphocyte cell count at 3-month follow-up assessment.	3-month assessment